Status:
COMPLETED
Is Analgesic Effect of Low Dose Ketamine-midazolam the Same as Morphine
Lead Sponsor:
Isfahan University of Medical Sciences
Conditions:
Closed Multiple Fractures of Upper and Lower Limbs
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
the investigators assessed the effects of low-dose IV ketamine-midazolam versus morphine on pain control in trauma patients with closed limb fracture(s); and also compared the incidence of adverse eve...
Detailed Description
this prospective, single blind, noninferiority trial randomized consecutive ED patients aged 18 to 60 years to two groups: receiving either 300-500 mcg ketamine plus 0.03 mg midazolam, or 0.05 to 0.1 ...
Eligibility Criteria
Inclusion
- Between 18 and 60 years
- Patients with closed limb fracture(s)
- VAS score of at least 6
Exclusion
- Acute pulmonary infection
- Previous coronary artery diseases,ACS,congestive heart failure,
- suspected aortic dissection
- History of uncontrolled hypertention or blood pressure \> 140/90mmHg
- Brain injury with focal neurological deficit or loss of consciousness
- Central nervous system mass lesion,hydrocephalus, or other states with increased intracranial pressure
- Glaucoma and acute globe injury
- History of porphyria
- Previous hyperthyroidism or thyroid hormone replacement
- Pregnancy or laction
- Major psychiatric disorder
- Previous allergic reaction to the agents administered in the study
- Patient declined to provide written informed conse
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT01807429
Start Date
December 1 2012
End Date
February 1 2013
Last Update
March 8 2013
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